Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
ConditionKetosis Prone Diabetes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.
Eligibility criteria
Qualifiers
Provide informed consent
Have a BMI ≥ 28 kg/m2
Be of African American ancestry
Meet diagnostic criteria for DKA. Diagnostic criteria for DKA will include a plasma glucose > 250 mg/dl, a venous pH < 7.30, a serum bicarbonate < 18 mmol/l, and serum ketones (beta-hydroxy butyrate) > 1.5 mmol/L.
Disqualifiers
Significant medical or surgical illness including but not limited to myocardial ischemia, congestive heart failure, chronic peripheral venous insufficiency, chronic renal insufficiency, liver insufficiency (serum transaminases 3 times the upper limit of normal) and acute or chronic infectious processes
Have recognized uncontrolled endocrine disorders such as hypercortisolism, acromegaly, or hyperthyroidism
Anemia (hemoglobin < 12.5 g/dL for men, <11.5 gm/dL for women), bleeding disorders, or abnormalities in coagulation studies
Pregnant
Trial design
Treatments tested in this trial
- Continuous Glucose Monitoring
- Insulin
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov